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Researchers call for greater transparency of artificial intelligence/machine learning training and validation datasets in devices ...[ Price : $8.95]
FDA approves an Ionis Pharmaceuticals NDA for Dawnzera (donidalorsen) as the first RNA-targeted prophylactic treatment for heredit...[ Price : $8.95]
AbbVie reports that its JAK inhibitor Rinvoq (upadacitinib) met primary and secondary endpoints in a pivotal Phase 3 study testing...[ Price : $8.95]
An in-depth ProPublica report details the effects of massive staffing cuts at FDA and other HHS agencies that experts say threaten...[ Price : $8.95]
14 states join a petition submitted by four other states calling on FDA to eliminate the mifepristone REMS requirements in their s...[ Price : $8.95]
FDA publishes a guidance with recommendations for 510(k) animal studies for dental bone grafting material devices.[ Price : $8.95]
FDA publishes a draft guidance with recommendations for approaches to assessing overall survival in oncology clinical trials.[ Price : $8.95]
FDA grants Keros Therapeutics an orphan drug designation for its investigational therapy KER-065 and its use in treating Duchenne ...